Insys Therapeutics (INSY) Stock Soars After FDA Approves Syndros

Shares of Insys Therapeutics Inc. (INSY) were trading up +2.73 or +20.27 percent to $16.20 per share in this morning’s premarket after news broke early this morning that the company had received FDA approval for Syndros, a treatment for anorexia associated with weight loss in AIDS patients. Insys Therapeutics stock closed at $13.47, up +0.53 or +4.10 percent in Friday’s regular trading session.

Stock Analysis

Chandler, Arizona based Insys Therapeutics Inc. was founded in 1990 by billionaire John N.

Kapoor who continues in the role of director and executive chairman. Insys Therapeutics is a specialty pharmaceutical company focusing on the development and commercialization of innovative drugs and drug delivery systems of therapeutic molecules for the improvement of the quality of life of patients. The company currently markets one product: Subsys, a fentanyl sublingual spray. However, with today’s approval, the company will begin marketing its second product, Syndros. Insys is currently developing a pipeline of sublingual sprays for potentially treating opioid addiction and overdose, epilepsy and other areas of disease with a high unmet need.

In this morning’s press release, Insys announced that the U.S. Food and Drug Administration had approved Insys’ dronabinol oral solution, Syndros. The drug is an orally administered liquid formula of the pharmaceutical cannabinoid dronabinol. Dronabinol is a pharmaceutical version of tetrahydrocannabinol or THC found in the cannabis plant.

The FDA approved Syndros for the treatment of anorexia associated with patients with weight loss due to AIDS, and treatment of chemotherapy patients with nausea and vomiting which did not respond to other antiemetic treatments. Syndros is still awaiting scheduling by the U.S. Drug Enforcement Administration.

Insys’ Chairman, Chief Executive Officer and President, Dr. John N. Kapoor stated in this morning’s press release that, “Syndros is the first and only FDA approved dronabinol solution for oral use. It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect. Once Syndros has been opened, it does not need to be refrigerated for 28 days. We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth. We expect that Syndros’ attractive profile will enable rapid market conversion and expansion, making for a significant long-term commercial opportunity for Insys”.

The company’s press release included safety information on Syndros. According to Insys, Syndros could cause cognitive effects and impair physical and/or mental abilities. Insys warned that patients with cardiac disorders could experience hypertension, hypotension, syncope or tachycardia. Patients using medications containing disulfiriam or metronidazole are advised to discontinue treatment 14 days before taking Syndros and not to take the medication for seven days after treatment with Syndros.

Currently, approximately 9,500 prescribers account for seventy percent of dronabinol prescriptions, which Insys says it expects to convert a large portion of this market to Syndros. In addition, Insys will expand the market through direct contact with physicians, highlighting Syndros improved product profile. Insys anticipated the launch of Syndros in the second half of this year.

Private equity firm Gores Group will buy the company for $725 million and take it public.

Published on Jul 5, 2016

By Jay Hawk

Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.